key: cord-0835363-hscutoi5
authors: He, Hejie; Datla, Sushma; Weight, Nicholas; Raza, Sidra; Lachlan, Thomas; Aldhoon, Bashar; Panikker, Sandeep; Dhanjal, Tarv; Yusuf, Shamil; Foster, William; Hayat, Sajad; Osman, Faizel
title: Safety and cost-effectiveness of same-day complex left atrial ablation
date: 2020-09-28
journal: Int J Cardiol
DOI: 10.1016/j.ijcard.2020.09.066
sha: c6e8ca061b4efb61c9799e607c9d4b975cbdf9f3
doc_id: 835363
cord_uid: hscutoi5

BACKGROUND: Catheter ablation for complex left-atrial arrhythmia is increasing worldwide with many centres admitting patients overnight. Same-day procedures using conscious sedation carry significant benefits to patients/healthcare providers but data are limited. We evaluated the safety and cost-effectiveness of same-day complex left-atrial arrhythmia ablation. METHOD: Multi-centre retrospective cohort study of all consecutive complex elective left-atrial ablation procedures performed between January 2011 and December 2019. Data were collected on planned same-day discharge versus overnight stay, baseline parameters, procedure details/success, ablation technology, post-operative complications, unplanned overnight admissions/outcomes at 4-months and mortality up to April 2020. A cost analysis of potential savings was also performed. RESULTS: A total of 967 consecutive patients underwent complex left-ablation using radiofrequency (point-by-point ablation aided by 3D-mapping or PVAC catheter ablation with fluoroscopic screening) or cryoballoon-ablation (mean age: 60.9 ± 11.6 years, range 23-83 yrs., 572 [59%] females). The majority of patients had isolation of pulmonary veins alone (n = 846, 87%) and most using conscious-sedation alone (n = 921, 95%). Of the total cohort, 414 (43%) had planned same-day procedure with 35 (8%) admitted overnight due to major (n = 5) or minor (n = 30) complications. Overall acute procedural success-rate was 96% (n = 932). Complications in planned overnight-stay/same-day cohorts were low. At 4-month follow-up there were 62 (6.4%) readmissions (femoral haematomas, palpitation, other reasons); there were 3 deaths at mean follow-up of 42.0 ± 27.6 months, none related to the procedure. Overnight stay costs £350; the same-day ablation policy over this period would have saved £310,450. CONCLUSIONS: Same-day complex left-atrial catheter ablation using conscious sedation is safe and cost-effective with significant benefits for patients and healthcare providers. This is especially important in the current financial climate and Covid-19 pandemic.

Complex left-atrial catheter ablation is frequently performed for atrial fibrillation (AF) and atypical atrial flutter/atrial tachycardia. These procedures involve trans-septal puncture and patients are routinely kept overnight to observe for possible complications. 1 Overnight-stay has higher costs compared with same-day procedures. Studies evaluating same-day catheter ablation for AF 2,3 and catheter ablation more widely 4 have suggested same-day ablation is safe, effective 5 and has significant cost-savings for healthcare providers. [6] [7] [8] Same-day ablations may benefit patients/healthcare providers by reducing logistic constraints on hospital resources, especially in the current financial climate and Covid-19 pandemic, the latter making overnight hospital-stay challenging. We previously reported same-day standard catheter ablation was safe and cost-effective 6 but data on complex left-atrial ablation are limited. We started performing same-day complex left-atrial ablations in 2016 and wanted to evaluate the safety and efficacy of this policy. We also performed a cost-analysis of potential savings possible by adopting this same-day ablation policy. Our protocol for same-day complex left atrial ablation started in January 2016 for cryoballoon ablations and June 2017 for 3D-radiofrequency (RF) point-by-point ablations with contact-force sensing. We included all consecutive patients requiring left-atrial ablation (needing trans-septal puncture from outset) chronologically from these dates. Where possible those living further away from the hospital were listed earlier than those living closer to allow timely discharge. Age and geography were not specifically used to exclude patients; exceptions to same-day discharge were allowed on the day at the operator's discretion. Those Patients were anticoagulated pre-procedure with arrhythmia mechanism and ablation strategy formulation in accordance with published guidelines. 9 Unilateral femoral-venous access was performed for PVAC/cryoballoon and bilateral for 3D-RF cases. Duration of 3D-J o u r n a l P r e -p r o o f RF application was determined by Force-Time-Integral, 10 Lesion-Size-Index 11 or Ablation-Index. 12 A transthoracic echocardiogram (TTE) was performed in all immediately postprocedure with repeat 2-3hrs later; protamine 50mg was administered post-op and femoral haemostasis achieved using digital manual pressure or a 'figure-of-8' (Z) suture 13 using the same-day protocol.

Details of immediate (<4hrs post-procedure) and short-term (>4hrs-24hrs) complications were collected in addition to need for overnight-stay and readmissions at 4months post-ablation, as well as mortality up to April 2020. The cost of monitored overnightstay was obtained and potential savings of adopting the same-day ablation policy during the study period calculated.

All data were analysed using Statistical Package for Social Sciences (SPSS), version 26.0 (IBM, Chicago, Illinois). Continuous variables were expressed as mean ± standard deviation (SD) and nominal data as number and percentage. We compared categorical variables using Chi-squared test and continuous variables using the independent t-test.

A total of 967 patients underwent complex left-atrial ablation (mean age: 60.9±11.6years; 572 [59%] female). The majority were performed using LA and conscious sedation only (n=921, 95%); the commonest arrhythmia was paroxysmal or persistent AF (n=846, 87%). Of the total, 414 (43%) were planned same-day discharge procedures. Complete procedural success was achieved in 932 (96%) with an overall procedure duration of 159±76.4mins. Table 1a shows a comparison of baseline and procedure data between same-day versus overnight-stay cohorts.

There were a total of 46 (4.8%) immediate complications (16major/30minor) and 34 (3.5%) short-term complications (3major/31minor) (Table 1b) ; all immediate complications occurred within 2hrs post-procedure with pericardial tamponade requiring drainage in 10 (1%). Femoral haematomas needing surgical intervention occurred in 5 (0.5%). One patient developed acute pulmonary oedema of unknown cause, requiring invasive ventilation and intra-venous diuretics. Reversible phrenic nerve palsy was noted in 9 (0.9%) cryoballoon cases (all recovered within 24hrs) and stroke in 2 (0.2%); none needed cardiac surgery due to procedural complications. During 4-month follow-up there were 62 (6.4%) hospital readmissions for a variety of reasons: 9 femoral bleeds, 1 pericardial-effusion needing drain, and 2 late-presentation heart-blocks needing pacing (Table 1b) . Of the 2 pacemakers, one presented 4weeks post-cryoballoon with intermittent complete heart-block and the second 6weeks post RF-ablation, both unrelated to the ablation. There were no differences in femoral complications between unilateral versus bilateral venous-punctures (1.7% vs 1.8%, p=0.7 respectively). Overall complications were no different between cryoballoon versus 3D-RF (4.0% vs 5.0%, p=0.49 respectively) or GA versus conscious-sedation (2.6% vs 4.7%, p=0.54 respectively) cases.

Of those discharged same-day, none developed complications within 24hrs that would otherwise have been detected by overnight-stay. There were 86 (20.8%) unplanned overnight admissions, of which 34 were for immediate/short-term complications (as above), 25 admitted at operator discretion and 27 for non-procedure related reasons (late-finish, medication-dispensing delays). There were 3 deaths at mean follow-up of 42.0±27.6months, none related to ablation.

Overnight-stay, excluding any other procedures, costs ~$500 (£350). Our same-day policy over this period resulted in 327 patients (413 minus 86 unforeseen admissions) discharged same-day resulting in a $163,500 (£114,450) cost-saving. However, if the sameday policy was applied to all during the study period (excluding 79 who had post-procedure complications) $443,500 (£310,450) could have been saved.

Same-day complex left-atrial catheter ablation, performed using pain relief and conscious sedation, is safe and associated with few complications with a minority requiring overnightstay or hospital re-admission. Data on same-day complex left-atrial ablations are limited 3, 7, 8 with many centres admitting patients overnight, which has inherent cost-implications and is associated with significant risk given the Covid-19 pandemic. 14 Performing same-day complex left atrial ablation can help mitigate risk of Covid-19 transmission and reduce costburden on healthcare providers worldwide.

We previously reported standard same-day ablation was safe/cost-effective; 6 applying the same principles to complex left-atrial ablation could have significant benefits. Opel et al 8 demonstrated safe and successful same-day AF cryo-ablation. Utilising a same-day strategy for all left-atrial ablations irrespective of ablation technology could significantly reduce logistic constraints on hospitals, especially given the increasing volume of such cases being performed worldwide. 9 This is even more important with the high demand for inpatient beds by services such as Acute Medicine, resulting in elective procedure cancellations and delays.

In our study 20% same-day patients had unplanned overnight-stay, with the majority not due to a complication. This was likely related to the initiation phase of the same-day protocol, with operators initially being over-cautious, and logistics constraints caused by late J o u r n a l P r e -p r o o f finishes/patients living further away. These considerations can limit implementation of the same-day policy but are not insurmountable with careful planning/experience. Overall we noted low complications and high acute procedural success. Most immediate and short-term complications were femoral haematomas/bleeding (n=37, 3.8%) and only 5 (0.5%) needed surgical intervention. Interestingly, lack of use of TOE did not appear to confer disadvantage as our stroke/transient ischaemic attack rate was very low although we did not screen for silent-strokes as this is not recommended in guidelines. 9 We reported two stokes in our cohort and therefore recognise that pre-op TOE may have identified intra-cardiac thrombus which would have aborted the procedures. Our cost-analysis suggests significant savings are possible with same-day ablations. Cases cancelled due to overnight-bed unavailability result in worse outcomes and unnecessary delays. The technologies used in our study reflected real world practice with both RF and cryo-ablation included. Previous authors have shown same-day AF-ablation is safe and effective, 3, 7, 8 however, these have had small same-day numbers, 7 used single-technology (cryoballoon) 8 or were done only under GA. 3 To date, no recommendations have been made about same-day complex left-atrial ablations in international guidelines. 9 The current study is from an experienced high-volume centre. Our findings would apply to similar high-volume centres and not centres with less patient volumes/operator experience as previous studies have outlined the role that less experience plays in patient safety. 9

We had no data on morbidity at longer-term follow-up. Additionally, it is possible some may have developed minor complications (e.g. small groin-haematomas) that may have resolved spontaneously before 4-month follow-up and for which the patient may not have sought medical advice. This could result in under reporting of minor complications. Also, certain J o u r n a l P r e -p r o o f arrhythmias (such as left-atrial tachycardia) were limited in number. Our study was nonrandomised with no control group. Also, our historical overnight-stay comparison group has limitations given the advances in technology/procedural-care that have occurred during the study time-period.

Complex same-day left atrial ablation is safe, cost-effective and has significant benefits for patients and healthcare providers. This is particularly important in the current climate when hospitals are facing enormous challenges, both clinical and financial.

J o u r n a l P r e -p r o o f Table 1a Comparison of baseline and procedure data between same-day and overnight-stay cohorts Table 1b Immediate/short-term complications, readmissions at 4month follow-up and mortality We have previously reported same-day standard catheter ablation is safe, feasible and costeffective. Data on same-day complex left-atrial ablation are limited.

Our multi-centre cohort study of 967 consecutive elective complex left-atrial ablation procedures between January 2011 and December 2019 revealed same-day ablations using conscious sedation were safe and associated with very few complications and could have significant benefits to patients and cost-savings for healthcare providers worldwide.

Same-day complex left-atrial ablation procedures can be performed safely without the need for overnight-stay. This has major implications for both patients and healthcare providers, especially given the current financial challenges and Covid-19 pandemic.

J o u r n a l P r e -p r o o f

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Efficacy and Safety of Same-Day Discharge for Atrial Fibrillation Ablation

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Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation

Same-day cardiac catheter ablation is safe and cost-effective: Experience from a UK tertiary center

Same-day discharge in selected patients undergoing atrial fibrillation ablation

Comparison of a high throughput day case atrial fibrillation ablation service in a local hospital with standard regional tertiary cardiac centre care

Access Site Bleed/Haematoma (treated conservatively) 12 3 9 Pericardial Effusion (no drain) 6